SBIR Phase I: Development of a Novel, Sprayable, Large Volume Hydrogel Delivery System Platform

SBIR 第一阶段：开发新型、可喷雾、大容量水凝胶输送系统平台

• 批准号: 2304462
• 负责人: Greg Grover
• 金额: $ 27.5万
• 依托单位: KARIOS TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2304462&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Novel; Sprayable

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a simplified system for applying compound in situ to form biomaterials during surgical procedures. Controlled biomaterial applications pose significant potential surgical advantages including for anti-adhesion, tissue sealant, and drug delivery purposes. The proposed platform will enable procedural consistency to provide new and improved ways to manage bleeding and reduce scar tissue formation during surgical procedures. This product aims to gain a share of the $1.5 billion adhesion prevention market and $1.2 billion hemostat market, and enable eventual site-specific delivery cells and drugs, depending on the biomaterial delivered. This Small Business Innovation Research (SBIR) Phase I project will develop a ready-to-use, large volume delivery system for in situ forming biomaterials. The scope of activities includes transferring a novel, proprietary, in situ biomaterial with applicability as a tissue sealant, scar tissue reductant, and drug/cell delivery vehicle, into a novel single use applicator. The prepackaged delivery system will formulate the suspended biomaterial with the resuspension solution using an internal mechanical mechanism which delivers the biomaterial in a controlled aerosolized manner suitable for clinical use. This Phase 1 project aims to complete and validate prototypes with lyophilized biomaterials within good manufacturing practices, engineer the design of the syringe barrel and delivery tips/nozzles, and complete laboratory validation in a manner suitable for first in human use.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业创新研究（SBIR）I阶段项目的更广泛的影响/商业潜力是一种简化的系统，用于在手术过程中施加化合物以原位形成生物材料。受控的生物材料应用具有明显的潜在手术优势，包括抗粘附，组织密封剂和药物输送目的。所提出的平台将使程序一致性能够提供新的和改进的方法来管理出血并减少手术过程中疤痕组织的形成。该产品旨在获得15亿美元的预防粘附市场和12亿美元的急诊市场的份额，并取决于最终的特定地点的递送细胞和药物，具体取决于交付的生物材料。这项小型企业创新研究（SBIR）I阶段项目将开发出一种现场形成生物材料的现成的，大量的交付系统。活动的范围包括将新颖的，专有的原位生物材料转移到具有组织密封剂，疤痕组织还原物和药物/细胞递送车辆的适用性中，成为一种新型的单次使用涂抹器。预包装的递送系统将使用内部机械机制通过重悬溶液来制定悬浮的生物材料，该机制以适合临床用途的受控方式提供生物材料。 This Phase 1 project aims to complete and validate prototypes with lyophilized biomaterials within good manufacturing practices, engineer the design of the syringe barrel and delivery tips/nozzles, and complete laboratory validation in a manner suitable for first in human use.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.